PhotoniCare, Inc. is a medical device company developing a handheld, biophotonics imaging system suitable for use by otolaryngologists (ear, nose, and throat specialists; ENT) and primary care physicians (PCP) to enable real-time, 3-D assessment of sub-surface tissue structure in the middle ear. Significance: ENTs and PCPs have limited tools with which to diagnose otitis media (OM), or middle ear infections. OM affects the vast majority of children and accounts for more than 25 million annual physician visits. The current standard diagnostic tool for evaluating the middle ear, the otoscope, is a basic magnifier of tissue surfaces and has limited diagnostic ability and repeatability. The ability to provide physicians with unprecedented, quantitative information about the middle ear will reduce diagnostic variability between physicians and provide a more accurate picture of middle ear health to optimize treatment strategies. Hypothesis: The presence of middle ear biofilms or highly purulent effusions will be indicative of long-term chronic ear disease, even in patients tha are early in the disease cycle, providing an early indicator of long- term disease and a non-invasive, observable metric by using our device. Specific Aims: (1) Build a commercial prototype handheld OCT system designed for ENT specialists to non- invasively image through the eardrum and into the middle ear. (2) Conduct a 100-patient clinical utility study in ENT and primary care settings to determine the clinical value of quantifiable effusion purulence and presence of middle ear biofilms. (3) Conduct a 35-patient clinical utility study in the ENT clinic o determine dependence upon clinical expertise required to extract meaningful data from the imaging system. The long-term goal of this project is to better understand the impact of bacterial biofilms and effusion purulence on disease progression and treatment strategies. Commercial Opportunity: This device will provide physicians with new and quantitative information related to middle ear disease, enabling better decision-making for interventional surgery (more rapid intervention for children that need it and reduction of unnecessary surgeries). Reduction of even 5% of surgeries represents $150M in savings to the U.S. healthcare system each year. Additionally, the ability to shorten the cycle of repeat visits before surgery represents a large savings to payers and patients, alike.